Bone Health Table 6 Prevention Studies Using Rehabilitation Modalities for Bone Health after SCI

Author Year; Country
Score
Research Design
Total Sample Size

Methods

Outcome

FES-cycle ergometer

Eser et al. 2003; Switzerland
Downs & Black =14
Prospective Controlled trial (nonrandomized)
N=38

Population: 38 men and women, mean age = 33, with complete injuries between C5-T12, (19 participants, 19 controls).
Treatment: FES-cycle ergometer. Progressive training sessions until able to cycle for 30 mins. Then 3x/wk for 6 mos. from this baseline. On the remaining 2days of the week there was passive standing. Control group performed 30 mins. of passive standing 5 days/week.
Outcome measures: CT

  1. Both groups had 0-10% decrease in tibial cortical BMD. There was no difference between groups for BMD after the intervention.

Electrical Stimulation (ES)

Clark et al. 2007;
Australia
Downs & Black =21
Prospective Controlled trial (nonrandomized)
N=33

Population: 33 men and women; 15 participants with tetraplegia and 18 participants with paraplegia; diagnosis range from AIS A-D.
Treatment: FES, 5 months
Low-intensity stimulation to leg muscles, 15 min, 2x/day 5 days/wk, 5 months (n=23); or control group (no treatment) (n=10).
Outcome measures: DXA at 3 wk, 3 and 6 months post injury.

  1. ES was safe and well tolerated, but there was only a minimal difference between groups for total body BMD only at 3 months post injury (p<.01). Other DXA measures (hip and spine BMD) did not differ between groups at any time point.

Shields et al. 2006a;
USA
Downs & Black =15
Prospective Controlled trial (nonrandomized)
N=6

Population: 6 men with complete injuries from C5-T10; started study within 4.5 months of injury. Within-participant design.
Treatment: ES at 1.5 times body weight for 3 yrs.Treatment leg only received a home program of ES to stimulate leg plantar flexors with 35-min protocol (4 bouts with 5-min rest between bouts) for 5x/wk.
Outcome measures: DXA tibial analysis protocol.

  1. There was a greater decline in bone mineral loss on the untrained limb compared with the trained limb (10% vs. 25%) (p<.05)

Shields et al. 2006b;
USA
Downs & Black =15
Prospective Controlled trial (nonrandomized)
N=7

Population: 7 men with complete injuries from C5-T10; started study within 4.5 months of injury. Within-participant design.
Treatment: ES at 1.5 times body weight; 2-3 yrs.Treatment leg only received a home program of ES to stimulate leg plantar flexors with 35-min protocol (4 bouts/d with 5-min rest between bouts) for 5x/wk).
Outcome measures: pQCT 4%, 38%, and 66% sites of bilateral tibiae.

  1. No significant difference at the tibial midshaft but a 31% higher distal tibia trabecular BMD in trained limbs compared with untrained leg.

Shields et al. 2007
USA
Downs & Black =15
Pre-Post
N=4

Population: 4 men with SCI; Age: 52.3±11.2 years; Level of injury: T1-7 (AIS A); TSI: 8.9±4.1 years.
Treatment: Trained 1 leg using an isometric plantar flexion electrical stimulation protocol (the untrained limb serving as within subject control) for 30min/day, 5 days/wk, for 6 to 11 months. Mean estimated compressive loads delivered to the tibia were ~110% body weight.
Outcome Measures: BMD by DXA

  1. Untrained limb BMD did not differ from trained limb BMD either before or after training.
  2. Unchanged BMD of proximal tibia before and after training for trained and untrained limb (P>0.05). Trained limb of 2 subjects had ~0.02g/cm2 gain in BMD but not statistically significant.

Standing/Walking

Ben et al. 2005;
Australia
PEDro=9
Within-participant RCT
N=20

Population: 20 men and women; 8 participants with paraplegia, 12 participants with tetraplegia. Within-participant design.
Treatment: Tilt-table standing, 12 wks.
Treatment leg only received weight bearing on a tilt-table for 30 min, 3x/wk.  Wedge applied to treatment leg to provide adequate dorsiflexion and weight bearing to the ankle. Control leg was not loaded in standing.
Outcome measures: DXA proximal femur.

  1. No clinically significant effect on proximal femur BMD in treatment group, but a 4 degree improvement in ankle mobility.

de Bruin et al. 1999; Switzerland
PEDro=6
RCT
N=19

Population: 19 men, ages 19-59, with injuries between C4-T12, all with diagnosis from AIS: A-D.
Treatment: Standing/Walking. Group 1 had 0-5 hrs per week loading exercises with standing frame. Group 2 had 5+hrs of standing exercises per week (standing). Group 3 had 5+hrs of standing and treadmill (walking). Interventions lasted 25 wks.
Outcome measures: BMD by pQCT

  1. Marked decrease in trabecular BMD at the left tibia for the immobilized group but minimal decrease in trabecular BMD in Group 2 and 3.

Treadmill training

Giangregorio et al. 2005; Canada
Downs & Black =13
Pre-post
N=5

Population: 2 men and 3 women, ages 19-40, with injuries between C3-C8 and diagnosis AIS B and C.
Treatment: Body-weight supported treadmill training. Initial session started at 5mins and was increased gradually to 10-15 mins in all but 1 participant during 48 sessions of 2x/wk-training over a period of 6-8 months.
Outcome measures:BMD byDXA and CT; bone turnover markers.

  1. Decrease in BMD for all participants at almost all lower limb sites after training, ranging from -1.2 to -26.7%.
  2. Lumbar spine BMD changes ranged from 0.2 to -7.4%.
  3. No consistent changes in bone geometry at distal femur and proximal tibia.
  4. Did not alter the expected pattern of change in bone biochemical markers over time.

Ultrasound

Warden et al. 2001;
Australia
PEDro=11
RCT
N=15

Population: 15 men, ages 17-40, with injuries between C5-T10 and diagnosis AIS:  A-B, (within group design).
Treatment: Pulsed therapeutic ultrasound. Applied to both calcanei for each participant for 20 min/day, 5x/wk over a consecutive 6-wk period. Right and left calcaneus within each participant was randomized.
Outcome measures:BMD by DXA and quantitative ultrasound (QUS).

  1. For specified dose, no significant effect of QUS for any skeletal measurement parameter (p>0.05).